FDA UDI
In Commercial Distribution
🇺🇸 United States
g.Nautilus PRO
DI: EBCI5730PRO0
·
Model: 19 FLEXIBLE channels
·
g.tec medical engineering GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- g.Nautilus PRO
- Primary DI
- EBCI5730PRO0
- Version / Model
- 19 FLEXIBLE channels
- Catalog Number
- 5730PRO
- Company Name
- g.tec medical engineering GmbH
- Labeler DUNS
- 300916041
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-28
- Public Version
- 1
- Public Version Date
- 2024-06-05
- Public Version Status
- New
- Public Device Record Key
- 5ce7448d-5852-41de-b6d5-e772b66e19dd
Device Description
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
| GWL | Amplifier, Physiological Signal | Neurology | 882.1835 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32521 | Multiple physiological signal amplifier | An electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EBCI5730PRO0 | HIBCC |
Customer Contacts
- Phone
- +437251222400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171669 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 25 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 45 Degrees Celsius